As the close of 2023 approaches, the US Food and Drug Administration (FDA) has issued draft guidance detailing its new Advanced Manufacturing Technologies Designation Program, intended to facilitate ...
The U.S. Food and Drug Administration announced Thursday that it will be phasing out a requirement that monoclonal antibodies and other drugs be tested on animals, saying in a news release that there ...
FDA Commissioner Martin Makary on Thursday announced a move away from animal-based drug testing in favor of human-based methods and artificial intelligence to determine drug safety and effectiveness.
Emrelis is the first FDA-approved antibody drug conjugate for advanced NSCLC with high c-Met protein overexpression, addressing a critical unmet need. The phase 2 LUMINOSITY study showed a 35% overall ...
When we imagine the process of developing new drugs, we often picture scientists working with cutting-edge technology in gleaming laboratories. But there’s a side of pharmaceutical research that is ...
Discover how advanced detectors are driving improvements in biopharma quality assurance by enhancing precision across ...